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FDA 510(k) Application Details - K230999
Device Classification Name
More FDA Info for this Device
510(K) Number
K230999
Device Name
INT Vacuum Locking Syringe
Applicant
Shanghai Kindly Medical Instruments Co.,Ltd
No.925,Jinyuan yi Road
Shanghai 201803 CN
Other 510(k) Applications for this Company
Contact
Jianhai Xu
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2023
Decision Date
02/23/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K230999
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